FDA Announces Rate for Rare Pediatric Disease Priority Review Vouchers to Increase in 2016

September 30, 2015

FDA has released the fiscal year 2016 fee rate for using a rare pediatric disease priority review voucher. The new rate for 2016 will be $2,727,000, up from 2015’s rate of $2,562,000, and will take effect starting tomorrow, October 1, 2015.

The Food and Drug Administration Safety and Innovation Act (FDASIA) contains a “sunset clause,” which states that after FDA has granted its third rare pediatric disease priority review voucher, it will have exactly one year to award any additional rare pediatric disease priority review vouchers. After the one-year time-frame is up, however, FDA may not award any additional vouchers, but any vouchers already awarded, may still be redeemed. FDA awarded its third rare pediatric disease voucher on March 17, 2015, indicating that the program would be ending after March 17, 2016 unless Congress were to take action.

However, with this announcement, it appears as though FDA does not expect that the program will be ending this coming March. One way this could be possible, is if the Advancing Hope Act of 2015, introduced in the House of Representatives on March 23, 2015 by Rep. George Kenneth “G. K.” Butterfield (D–NC–1), is signed into law. This bill is intended to provide an incentive for pediatric drug development by making the rare pediatric disease priority review program permanent.

Do you have a product that may be eligible to receive a rare pediatric disease priority review voucher? We can help determine if your product is eligible and, if so, we can help you obtain the voucher and, ultimately, receive FDA approval for your product. For more information on our services and how we can be of assistance, please contact us



Agency Alerts General Regulatory

September 30, 2015

FDA To Increase Tropical Disease Priority Review User Fee Rate In 2016

Starting October 1, 2015, the FDA tropical disease priority review user fee rate is set to increase to $2,727,000, up nearly $200,000 from 2015’s rate of $2,562,000. Under the Prescription Drug User...

Read More
Agency Alerts Regulatory Sciences

September 30, 2015

Rare Disease Day 2016: FDA Announces Grants for Natural History Studies in Rare Diseases

On Monday, February 29th, FDA celebrated the ninth annual Rare Disease Day by announcing its new grant program, which will award $2 million in research grants to fund natural history studies for rare...

Read More
Agency Alerts General Regulatory

September 30, 2015

FDA Prescription Drug User Fee Rates: Fiscal Year 2017

The Prescription Drug User Fee Amendments of 2012 (PDUFA V) allows FDA to collect user fees for the review of applications concerning human drug and biological products, the establishments where...

Read More